Contact PD/PI: Imperato-McGinley, Julianne L Admin-Core-001 (856) A. ADMINISTRATIVE CORE PROJECT SUMMARY/ABSTRACT During the past ten years the Weill Cornell Clinical and Translational Science Center (CTSC) has established an inclusive, strong and highly effective governance structure incorporating our partners as active members. As lead institution, Weill Cornell Medicine (WCM) serves as an academic home through which essential resources, technological tools and education programs can be efficiently shared and managed. The partner institutions comprising the CTSC are also neighbors located on York Avenue ?The Translational Research Avenue?. Within the immediate area are: Memorial Sloan Kettering Cancer Center (MSK); Hospital for Special Surgery (HSS); Hunter College (HC), School of Nursing (HCSON) and its Center for Translational and Basic Research (CTBR)/Research Center for Minority Institutions (RCMI), School of Urban Public Health; and the Animal Medical Center. In addition to this partnership, the CTSC has extensive ties to both Cornell University, Ithaca (CU) (particularly with the Nanobiotechnology Center, the Schools of Bioengineering and Veterinary Medicine), The McGovern Center for Venture Development and to the Burke Medical Research Institute for Rehabilitation, White Plains NY. The resulting cluster of institutions forms a unique and cohesive biomedical complex fulfilling the NCATS roadmap initiative of breaking-down institutional and disciplinary silos to accelerate translational research. Individually, the partner institutions are superb centers of intellectual and academic excellence. Their integration into the CTSC harnesses their distinctive characteristics, hastening clinical and translational research breakthroughs for improved patient care. The CTSC Administrative Core is tightly integrated with Evaluation and Continuous Improvement and Quality and Efficiency. Administration oversees the management of the CTSC, including introduction of the Balanced Scorecard approach. Evaluation and Tracking accomplishes the assessment of translational research and training innovations, introducing in this cycle the integration of the Results Based Accountability framework central to CTSA Common metrics, and the idea of targeted micro- experiments that can lead to multi-hub pilot studies and eventual impact on the CTSA network and the field. The Quality and Efficiency section enhances trial efficiency and recruitment through the introduction of a CTSC Performance Management Team. The Performance Management Team (PMT) will be the mechanism by which the CTSC improves research process performance. It will incorporate both the Balanced Scorecard approach used by the AC and the Results-Based Accountability approach that is the foundation of the CTSA Common Metrics effort. Project Summary/Abstract Page 356 Contact PD/PI: Imperato-McGinley, Julianne L Admin-Core-001 (856) ! A. ADMINSTRATIVE CORE FACILITIES AND RESOURCES Organization and Governance CTSC Administrative and Translational Research Home The CTSC headquarters is located on the 2nd floor of a five-story, 50,000 square foot building, the Feil Research Building and occupies a fully furnished and equipped 8300 square feet of space. The renovation project totaled $75 million and WCMC provides the space to the CTSC rent free. CTSC offices also include conference rooms, an education center, and state-of-the-art videoconferencing equipment. ! Also see Overall Facilities and Resources for more extensive Descriptions. . Quality and Efficiency Component The Joint Clinical Trial Office (JCTO) is under the long-time direction of John P. Leonard, MD, a nationally prominent clinical researcher with more than 15 years? experience. The JCTO is staffed by six (6) regulatory coordinators, eight (8) research nurses, and more than 20 data coordinators. The office operates under NCI CCSG guidelines and it is responsible for the protocol review and monitoring system. In 2013, WCM and NYP launched a Joint Clinical Trials Office (JCTO) to foster and advance clinical research programs. This collaboration was established in recognition of the need to provide support to investigators in these endeavors. The JCTO aims to provide a coordinated effort to facilitate high impact projects that are synergistic with other institutional goals while ensuring compliance with regulatory standards. The JCTO ?umbrella? encompasses a wide array of initiatives that contribute to the multidisciplinary components of clinical research. The clinical trial operations unit, comprised of general medicine and cancer, focuses on investigator support and training, study design and feasibility and facilitating access to resources that streamline the conduct of clinical trials.The business operations team assists with financial management and budgeting, study tracking, research subject recruitment, contracting with research sponsors and other administrative areas. The JCTO seeks to partner with investigators and other WCM/NYP departments and divisions in order to facilitate our clinical research enterprise, as well as to synergize with our patient care, educational, and laboratory research programs. The JCTO is responsible for negotiating budgets and contracts with sponsors, and has developed streamlined workflows that favor cross-institutional collaborations and that can now be extended to future multi-site clinical studies throughout the center, as required by the TICs and other NIH trial networks. IRB and Ethical Human Subject Research The human research protection program (HRPP of the WCM Office of Research Integrity (ORI) recently restructured its IRB office to more efficiently and rapidly handle the review of human subject studies. The IRB now includes five separate boards (four full committees and one expedited committee) and has eight full board meetings per month. There are also increased IRB administrative staff and a more defined organizational structure meet increasing demands. WCM is currently in the process of developing a standing audit program to ensure regulatory compliance for all WCM clinical studies, regardless of sponsor. The audit program will assess regulatory and protocol compliance with WCM institutional policies, International Council on Harmonisation-Good Clinical Practice, and applicable federal, state and local regulations; identify areas of improvement, and assist investigative teams with creating effective corrective and preventative action plans (CAPAs). The newly developed program will also include reviewing drug accountability and conducting inspections of WCM research pharmacies. This will assist in the review of drug dispensation and disposal, and verify compliance with WCM pharmacy SOPs. Institutional Animal Care and Use Committee (IACUC) As federally mandated by provisions in the Animal! Welfare! Act! (AWA) and the Health! Research! Extension! Act! of! 1985, Weill Cornell Medical College's (WCMC) Institutional Animal Care and Use Committee (IACUC) is charged with oversight of the WCMC's Animal Care and Use Program. Its membership is comprised of practicing scientists experienced in research involving animals, veterinarians with experience in laboratory animal medicine and science, nonscientists or lay members representing community interests, and at least one ! Facilities & Other Resources Page 357